Bristol-Myers’ lung cancer application granted Priority Review by FDA

Bristol-Myers (BMY) announced that the FDA accepted its supplemental Biologics License Application for Empliciti – elotuzumab – in combination with pomalidomide and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. The FDA granted the application priority review with an action date of December 27. The application is based on data from ELOQUENT-3, a randomized Phase 2 study evaluating the addition of Empliciti to pomalidomide and low-dose dexamethasone in patients with RRMM. Bristol-Myers Squibb and AbbVie (ABBV) are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities.

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